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Vaccines, Blood & Biologics

Record of Telephone Conversation, September 5, 2012 pm - Flucelvax


Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 05-Sep-2012 09:15 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Other -
Telecon Summary:
Need BPL reports with data for the 1.1 method
FDA Participants: Brenda Baldwin, Timothy Fritz, Timothy Nelle, Anissa Cheung, Xianghong Jing
Non-FDA Participants:
Matthew Gollwitzer – Regulatory
Umang Shah -– Regulatory
Manish Vyas – Regulatory
Kerstin Platz – Regulatory
Karsten Kattmann – Site Head, Marburg
Holger Kost – Head of QC
Klaus Dieter-Diehl – Quality Control
Reinhard Wilms – Technology Development
Bjoern Jobst - Technology Development
Stefan Knapp – Head of QA
Manfred Brunen – Technology Transfer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
CBER stated that:
  • The validation approach for TR #294885 is different from the previous validation protocol (#234079) used to validate the removal of BPL for FCC ------(b)(4)------------- produced from the old process 1.0, and
  • The new SOP (293950) for the measurement of residual BPL (process 1.1) for the ------(b)(4)---------- used in the validation study and the assay validation data have not been submitted
NVD committed to provide SOP 293950 and BPL Validation Report (294026 – BPL Process 1.1 – V.03.REP.P141-01).
CBER noted that the ----(b)(4)--------- lots used to determine residual BPL from the 2012/2013 production campaign is not adequate and that NVD would also need to show data from the -----------(b)(4)--. NVD stated that the ------(b)(4)---- is essentially the same since the ---(b)(4)-------- is the only difference ----(b)(4)-----------------. CBER stated that at issue were the differences in the limit-test validation protocol, particularly the change in limit of quantitation from -------(b)(4)-----------------------.  CBER stated that NVD would need to test every US lot of ---(b)(4)---- with the total lots required for testing for the 2012/2013 season and 2013/2014 to be determined by CBER using the BPL ---(b)(4)-----------results. In addition, CBER stated that appropriate specifications for BPL levels need to be proposed and included as information in the package insert.
In a September 18, 2012 e-mail, NVD committed to performing residual BPL testing on all US lots for the 2012/13 season with the validated method as per Report 294026.  The specification on the ---(b)(4)-------- will be not more than (NMT) (b)(4) which is comparable to the US licensed Fluvirin -----(b)(4)---- product.  In parallel a study on BPL -----------(b)(4)------ will be initiated; however, results will not be available prior to the 2012/2013 season.  Based on the outcome of the proposed study and in conjunction with existing supportive data from process 1.0, NVD will propose discontinuing routine testing of BPL at the -----(b)(4)------- stage.  For the 2012 flu season a report with the results will be submitted as an amendment and for the flu season 2013 onwards the results will be reported in the annual strain change update.

Page Last Updated: 12/19/2012
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